Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult and Pediatric Patients With COVID-19

Regeneron Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: COVID-19

Treatments: Drug: casirivimab+imdevimab combination therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT04425629

R10933-10987-COV-2067

2020-003690-21 (EudraCT Number)

Details and patient eligibility

About

Phase 1

• To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo
• To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2

Phase 2

• To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2

Phase 3

• Cohort 1 (≥18 Years Old, Not Pregnant at Randomization)

  • To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo as measured by COVID-19-related hospitalizations or all-cause death

• Cohort 2 (<18 Years Old, Not Pregnant at Randomization)

  • To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo
  • To further characterize the concentrations of REGN10933 and REGN10987 in serum over time

• Cohort 3 (Pregnant at Randomization) • To evaluate the safety and tolerability of REGN10933+REGN10987

Enrollment: 10,078 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Has SARS-CoV-2-positive diagnostic test (from a sample collected ≤72 hours prior to randomization, using a validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, and an appropriate sample such as nasopharyngeal [NP], nasal, oropharyngeal [OP], or saliva)
• Has symptoms consistent with COVID-19, as determined by the investigator, with onset ≤7 days before randomization
• Maintains O2 saturation ≥93% on room air
• Is able to understand and complete study-related questionnaires (patients aged ≥12 years only)

Key Exclusion Criteria:

• Was admitted to a hospital for COVID-19 prior to randomization, or is hospitalized (inpatient) for any reason at randomization
• Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, mAbs against SARS-CoV-2 (eg, bamlanivimab), or intravenous immunoglobulin (IVIG) within 3 months or within 5 half-lives of the investigational product (whichever is longer) prior to the screening visit
• Prior, current, or planned future use of any of the following treatments: COVID-19 convalescent plasma, mAbs against SARS-CoV-2 (eg, bamlanivimab), IVIG (any indication), systemic corticosteroids (any indication), or COVID-19 treatments (authorized, approved, or investigational)
• Prior use (prior to randomization), current use (at randomization) or planned use (within 90 days of study drug administration or per current CDC recommendations, as applicable) of any authorized or approved vaccine for COVID-19
• Has participated, is participating or plans to participate in a clinical research study evaluation any authorized, approved or investigational vaccine for COVID-19

NOTE: Other Protocol defined Inclusion/Exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10,078 participants in 1 patient group

casirivimab+imdevimab low dose

Experimental group

Description:

Low dose or body-weight equivalent for those under 18 years of age.

Treatment:

Drug: casirivimab+imdevimab combination therapy